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Medium risk Drugs & MedicationsClass II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Updated January 26, 2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X. Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Is the PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled? Yes. This product was recalled by FDA on January 26, 2026. Details below.

What is recalled

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Brands affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1350-2026
Classification
Class II
Recalled
January 26, 2026
Read the official notice

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